Method of making and filling liquid-containing sterile packages such as blood bags

• US 4,332,122 A
• Filed: 06/23/1980
• Issued: 06/01/1982
• Est. Priority Date: 07/24/1978
• Status: Expired due to Term

• Current Assignee: Baxter Travenol Laboratories Incorporated
• Original Assignee: Baxter Travenol Laboratories Incorporated
• Inventors: Williams, Ronald A.
• Primary Examiner(s): Coan, James F.
• Application Number:
  US06/161,975
• Time in Patent Office: 708 Days
• Field of Search: 53/425, 53/426, 53/127, 128/272, 128/214.2, 128/214 R, 128/214 D
• US Class Current: 53/425
• CPC Class Codes: A61M 1/0209 Multiple bag systems for separating or storing blood components

Abstract

Packages or containers are formed for body fluids or other solutions within which autoclaved liquids such as anticoagulants are included. The invention, which is particularly suitable for donor blood bags, includes the use of a sterile connector to incorporate autoclaved liquids into sterilized packages that can, if desired, be made of materials that cannot be successfully autoclaved at high temperatures without deformation or discoloration thereof.

Claims

1. A method of preparing liquid-containing sterile packages comprising the steps of:

fabricating a package which has a normally empty fluid chamber and which can be effectively sterilized only by dry-sterilization techniques;

fabricating a dispensing container which has a normally empty fluid chamber and which can be effectively sterilized by wet-sterilization techniques;

sterilizing said package by a dry-sterilization technique with its fluid chamber empty;

introducing a liquid into the fluid chamber of said dispensing container;

sterilizing by a wet-sterilization technique said dispensing container and the liquid contained within its fluid chamber;

providing a sterile flow path between the fluid chambers of said wet-sterilized dispensing container and said dry-sterilized package;

transporting through said sterile flow path a premeasured unit of said sterilized liquid from out of the fluid chamber of said wet-sterilized dispensing container and into the fluid chamber of said dry-sterilized package;

sealing said sterile flow path; and

severing said wet-sterilized dispensing container from said now filled, dry-sterilized package.

2. The method of claim 1, wherein said step of providing a sterile flow path includes exposing opaque, thermoplastic material to radiant energy for fusing it into a sterile aperture.

3. The method of claim 1, wherein said step of providing a sterile flow path includes making a connection between said sterilized package and said sterilized dispensing container, and opening the connection under sterile conditions to form said sterile flow path.

4. A method for preparing liquid-containing sterile packages from non-autoclavable material, comprising the steps of:

selecting a non-autoclavable material that is unsuitable for withstanding autoclave conditions and that is especially suitable for prolonged storage of body fluids;

forming from said non-autoclavable material a package having an initially empty fluid chamber;

sterilizing by a dry-sterilization technique said non-autoclavable package with its fluid chamber empty;

selecting an autoclavable substance;

forming from said autoclavable substance a dispensing container having an initially empty fluid chamber;

introducing a fluid into the fluid chamber of the dispensing container;

sterilizing by a wet-sterilization technique said autoclavable dispensing container and the liquid contained within its fluid chamber;

providing a sterile flow path between said liquid filled wet-sterilized dispensing container and said empty, dry-sterilized package;

introducing through said sterile flow path a premeasured unit of said sterilized liquid from out of the fluid chamber of said wet-sterilized dispensing container and into the fluid chamber of said dry-sterilized package;

sealing said sterile flow path; and

severing said dispensing container from said now filled dry-sterilized package.

5. The method of claim 4, wherein said step of providing a sterile flow path includes exposing opaque, thermoplastic material to radiant energy for fusing it into a sterile aperture.

6. The method of claim 4, wherein said step of providing a sterile flow path includes connecting in a sterile manner said sterilized dispensing container with said sterilized package.

7. The method of claim 4, wherein said step of sterilizing said autoclavable dispensing container is at a temperature of at least about 114°

C.

8. The method of claim 4, wherein said step of sterilizing said autoclavable dispensing container is an autoclave step at a temperature of at least about 120°

C.

9. The method of claim 4, wherein said step of dry-sterilizing said non-autoclavable package comprises radiation sterilization at between about 1 megarad and 5 megarads.

10. The method of claim 4, wherein said step of dry-sterilizing said non-autoclavable package comprises gas sterilization.

11. The method of claim 4, wherein said step of dry-sterilizing said non-autoclavable package includes treating with ethylene oxide gas at a temperature between about 20°

and about 70°

C.